Therapeutic and Drug Delivery Devices

摘要

Therapeutic devices are instruments or structures that deliver pharmaceuticals, radiation, or biologics to the body for purposes of ameliorating a disease or potential disease condition. The use of biomaterials as delivery devices to treat disease represents a major growth market in advancing U.S. health care. Such advances include the development of systems based on novel delivery technologies currently being implemented by the pharmaceutical industry. Other systems, based on emerging delivery technologies, are just beginning to be understood, and these started entering the marketplace in the late 20~(th) century. The field continues to grow significantly and has begun to compete with conventional means of drug delivery for such conditions as heart disease, cancer, stroke, and diabetes, which are among the largest crippling and fatal diseases affecting the U.S. public today. With the current acceleration in the development of biomaterials, a plethora of potential delivery systems are either in the market, under development, or anticipated. New measurement methods are needed to characterize the properties of these new devices. In vitro methods must be developed for prototype designs. In vivo monitoring, through minimally invasive methods, will be needed to evaluate the efficacy of the delivery systems. Increasing numbers of researchers are involved in the development of new entities for the delivery of precise, controlled dosages to specific sites of the body. Hence, for consistency in tracking the effects of the treatments and for the health and safety of patients, there is a critical need for standards for measuring the dose, pharmacokinetics, efficacy, and untoward effects of treatments. This breakout session included nine non-NIST participants representing companies with interest in delivering radiation, pharmaceuticals, or chemicals using implanted or inserted devices. These representatives, along with others from standards organizations, determined several niches for NIST activity in the development of standards for this segment of the biomedical industry. These niches include: 1) exploring the trend coming out of the European Union (EU) in regulation requiring standards, 2) developing systems for determining release rates of drugs from different matrices and elimination from the body (pharmacokinetics), 3) developing reference hydrogel or pore size standards and a standard medium to mimic drug release in different body fluids (this would require FDA consultations), 4) developing new standards and methods for sterilization of new and emerging materials that are biologically based and may suffer from degradation by usual sterilization methods (maybe a series of degradable polymers to test sterilization methods), and 5) developing standards for destructive activity assay and dosimetry methods (or recommended practices) and transfer standards (to hospitals) for dose measurements (material/artifactual standards)